Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-24 @ 12:03 PM
NCT ID:
NCT03955861
Eligibility Criteria:
Inclusion criteria for PsA patients
Patients with PsA will be included if they meet ALL of the following criteria:
1. Aged ≥ 18 years
2. Fulfil the Classification criteria for PSA (CASPAR)
3. Have not previously had biologic disease modifying treatment for their PsA
4. Are due to commence on subcutaneous TNF inhibitor or secukinumab as part of their standard clinical care, in line with SPC for the product prescribed
5. Are able and willing to give informed consent and comply with the requirements of the study protocol NOTE: DMARD therapy will be permitted and used as per standard clinical practice
Exclusion criteria:
Patients will not be eligible if they meet ANY of the following criteria:
1. History of or current autoimmune rheumatic disease other than PsA
2. Previously received a biologic therapy for PsA
3. Receiving infliximab (IV TNF inhibitor)
4. Haemoglobin ≤9 g/dl
5. Known HUMAN immunodeficiency Virus (HIV), hepatitis C or B infection
6. Current oral steroids
7. Intramuscular steroids within 6 weeks of baseline (IA steroid injection will be allowed) assessment
8. Pregnancy or breast feeding
9. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness. -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03955861
Study Brief:
Protocol Section:
NCT03955861